Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, New York 10003, USA.
J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.
Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the U.S. Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10 sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials.
Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled, graded-dose study demonstrated efficacy and safety at low and medium doses.
晚期癌症患者疼痛对阿片类药物治疗反应不佳，这是临床面临的挑战。Nabiximols（美国商品名 Nabiximols，通用名 Sativex[GW 制药有限公司，英国威尔特郡]，尚未有国际非专利药品名称）是一种新型大麻素制剂，正作为该人群的附加治疗进行研究。在一项随机、双盲、安慰剂对照、分级剂量研究中，晚期癌症伴阿片类药物难治性疼痛的患者接受安慰剂或 Nabiximols 低剂量（1-4 喷/天）、中剂量（6-10 喷/天）或高剂量（11-16 喷/天）治疗。在 5 周的治疗期间，每天测量平均疼痛、最痛和睡眠中断情况；其他问卷评估生活质量和情绪。共 360 名患者随机分组，263 名患者完成研究。各组间无基线差异。Nabiximols 与安慰剂的主要分析（总体 P=0.59）30%缓解率无统计学意义。从基线到研究结束的平均每日疼痛的次要连续缓解分析显示，Nabiximols 组报告镇痛的患者比例总体上大于安慰剂组（P=0.035），特别是低剂量（P=0.008）和中剂量（P=0.039）组。在低剂量组，平均平均疼痛（P=0.006）、平均最痛（P=0.011）和平均睡眠中断（P=0.003）结果相似。其他问卷未显示出组间有统计学意义的差异。不良反应与剂量相关，仅高剂量组与安慰剂组相比无优势。这项研究支持 Nabiximols 在低剂量和中剂量水平的疗效和安全性，并为未来的试验提供了重要的剂量信息。
Nabiximols 是一种新型大麻素制剂，可能是阿片类药物难治性癌痛患者的一种有用的附加镇痛药。一项随机、双盲、安慰剂对照、分级剂量研究表明，低剂量和中剂量具有疗效和安全性。
